under this act -- i would like there to be a may cause. i have a problem with the main cause of the other part of the bell for the draft. we should at least have a main cause for offering a subpoena to someone, and so i would hope that would be something else we look at so i think there are some issues. we want subpoena power but for a reason. we just wanted to be at the whim with all due respect, dr. hamburg, and i yield back to enact let me ask you a question with regard to another area and that is the registration and fees collected from commercial importers. there has been a change in this draft from previous drafts we have seen. specifically, why should drug and device manufacturers to currently already paid an annual establishment fee required to pay a duplicative the and what

really are encompassed within this commercial importation the schedule? >> well, the importer fi refers to the use of on the individual's warrant the companies that are serving as the link between foods that are ground, processed, manufactured overseas, and being brought into the united states to be distributed to consumers here. and so they are not necessarily representing a given manufacturer, but it is a very important pontian because it is that bridge between what is happening on the international arena and was coming into this country for use.

>> specifically with regard to the drug and device manufacturers who currently already register and pay a fee, would you envision that they're going to have to pay an additional registration fee in addition to what the fda already collects from blacks and if so, why? >> in terms of the importer function, i need to go back and look to this issue to speculative devices because i don't know how the system is set up, whether the manufacturer that it is serving in that role or not, so i will look back. >> will you take a look at that? that is one that we need to look at and i don't think we ought to be duplicating what you already are doing because you have jurisdiction there. i think that would be unfair. let me ask you also quickly, with regard to and the tracing of food and, the tracing system that has been put in place for you to issue regulations.

it appears that that would include the reference to be able to have traceability and i am told that about seven add of every 10 eating establishments are not part of chain operations, they're just independence separate food operations. i am just curious as to whether or not you think that this would have a serious impact on the small business owners and you think we ought to do a cost-benefit analysis before we impose that kind of cost on these individuals? >> well, i think clearly we want to work with restaurant owners and small businesses in order to make sure that the systems are not too cumbersome but it is very important that they keep records because if there is a tainted food that is in their facility, the implications for the health of their business as

well as to the health of their consumers is very significant indeed, and i think that they would want to be able to assist in sharing their information about the where the fruits came from so that the trace back can occur and we can identify the source of an outbreak and control at. so i think there are very important links in the food supply chain and protecting health really depends on them keeping records. >> let me ask you, what has fda done to implement the current what i think is called the one up one back traceability requirements? what has been done to implement that? >> well, the one up one back has been in place as i understand it for a while now. but it has proven not to be adequate to really capture the

full life cycle of a product and that we really needed as we mentioned earlier the full supply chain to be documented in integrated, interoperability, not just fragments here and it's really key to successful and swift investigation of outbreaks in the ability to control the problem and prevent future exposures to contaminated food product. >> thank-you. just the way we are proceeding, mr. markey is going to go out and he is our last questioner for you, dr. hamburg. we have won the votes, we'll be right back after that and then we will start with the second panel so mr. mark kikkoman thank you mr. chairman very much, congratulations dr. hamburg. you may know that i have a bill that calls for bpa to be banned

from being used in food and beverage containers because of the risks that have been identified. we have also recently learned that food and chemical industries have launched a public-relations campaign opposing any efforts to deal with this issue. is the fda concern about bpa? and what does the fda plan to do about those concerns? >> well, we are concerned. certainly i am aware of some of the study is that have raised issues in an animal populations in some of the information about bpa in many components of the food supply. we are starting to see activities at the local and state level in terms of action

with respect to bpa and i would hope that fda could really be providing leadership on some of these issues of assessing and analyzing resco. we are taking another look at the bpa issue, the acting chief scientist of the fda has been asked to take the lead on this because, of course, this is a decision where we have to bring the best available scientific data to bear. we need to look at all of the studies and examined them. but it is an issue of great consequence for americans. as a mother as well as a physician, it's an issue that i think we need to look as seriously and afford to be able to come back with some reports from a serious look at is being taken and we expect that it is going to be a task for him over

the summer to leave this review. by the end of the summer beginning of all we come to be able to put forward a fresh look at the bpa issue. >> the you have any advice for parents who are concerned about their children ingesting this chemical? >> well, i think, of course, parents are concerned can find alternatives that don't have bpa. and for the most part i think that those alternatives are pretty clearly labeled and pretty available and i think anyone with concerns, you know, should do so. >> okay, thank you for your work on this and if you could keep us posted on the progress you are making an evaluation, thank you so much. thank you mr. chairman. >> thank you very much dr. hamburg. as we have said, we do intend to

move toward on this bill next week and we appreciate your input and whenever, as you have to give us by next monday. my intention is we have one vote, we'll come back and hear from our second panel. thank you. >> thank you for your leadership on this important issue. [inaudible conversations] [inaudible conversations] [inaudible conversations]

[inaudible conversations] >> the subcommittee will reconvene in. and i see our second panel is already seated. let me introduce you to view. on my left is missile -- mr. michael ambrosio from a. representing the food marketing quality assurance issue. next we have a ms. pamela bailey who is president and chief executive officer of the grocery manufacturers association, and then we have met miss caroline smith dewaal, who is the safe food coalition food safety director of the center for science in the public interest. dr. tim jones who was the state of pd -- epidemiologist from the tennessee department of health, and last is mr. thomas stenzel

who is president and ceo of united fresh produce association. well, you know it is five minutes and obviously your staymans become part of the record if you -- if you want to include material more than a five minutes, and we all heard before, i know some of you wondered if you could meet the deadline, but since we do intend to go to market next week i agreed with what -- you brought it up -- mr. shimkus said it will give you any additional written timon and we like them back by monday at the end. so we will start with michael ambrosio. thank you for being here again. >> thank you, chairman pallone, members of the subcommittee come i'm honored to appear on behalf of the food marketing institute to present our views and suggestions on the food safety enhancement act discussion draft. which of the common goal of enacting legislation this year

that will genuinely improve the safety of the food supply. steps that prevent the presence of adulterants in the food supply are only true way to improve the safety of our food and i'm vice president of quality of insurance and i have been in charge of food safety programs for to 30 years. about it in 1946, we have grown from small struggling cop and into the nation's largest retailer non farm cooperative in the united states. we're had bernanke speaker new jersey, along with the store's employees over 47,000 individuals in new jersey, new york in something of a delaware, massachusetts, rhode island and maryland. today i am representing national trade association that has 1500 member companies made up of food retailers and wholesalers in the u.s. and around the world. at them i never saw. approximately 26,000 retail boosters with combined annual sales of roughly $400 billion representing three-quarters of

all retail food store sales in the u.s.. that fmi membership is composed of regional chains as well as independent grocery stores here this morning out presents several of fmi recommendations for revising the bill but i ask my entire salmon be included in the record. in april 2008i testified before the subcommittee on legislation now have modernized overhaul the food safety systems that the food and drug administration and since that time high profile of to say the operation recalls involving tomatoes, jalapenos, peanuts and mustachios have not only it had guns but regrettably acosta listen in some cases even that. many of the themes and ideas that i share today will be similar to those i shared in 2008 but their differences the reflect lessons learned and new witnesses in the existing food safety system identified from the latest recalls. as the purchasing agent for the concern and of the supply chain our industry understands it is vital to ensure that the fda

have necessary authority and resources to meet the challenges of today's global marketplace. consumer confidence remains an essential factor in this debate, food safety issues can be extremely complex and consumers weary greatly in their knowledge of the science and other issues affecting the safety of our food supply. however, as food safety issues drawn national headlines consumer awareness is well concern about the safety of commercially prepared food and products purchased at the supermarket tie-ins. mr. chairman, i applaud you, chairman waxman and all members of the committee for your efforts to address changes needed to improve our food safety system. we support many of the proposals in the draft by emphasizing the need to have preventive measures been the foundation on which the food safety system should be built. the draft also recognized we need to focus on a majority of resources on facilities and products that pose greatest risk of contamination that could result in foodborne illness or injury and now we must continue to be sure that any changes in

certain criteria and supported by science and i have measurable benefits, be affordable, be realistic and be implemented without unintended consequences. first we applaud you for not only designating an entire section of the bill to prevention but also putting this first and most extensive section of the bill. in harper's by the of this is the proper emphasis. addition out like to specifically comment on certain sections of the draft. fmi recognizes strong public-private partnership is needed to help insure safety of the food supply although every penny counts in these tough economic times, there is nothing more important in improving and insure the safety of our food supply. we are willing to support a thir registration or user fee provided in is utilized by the fda in a chance and an accountable manner to improve the safety of our food supply through means such as connecting researching consumer education programs. we look for to working with the committee to address our concerns about how the fda and may utilize any fees collected

and we support the requirement that every registered for a facility conduct risk assessments and implement and maintain relative food safety plan and identify potential resources of contamination and of proper food safety controls and document those controls that will eliminate potential hazards here and adherence to food safety plans goes a long way toward developing a culture within a company that is critical to ensuring food safety. mr. chairman, thank you for the opportunity to testify, we appreciate the work that has gone into development of the food safety enhancement act discussion draft with the goal of improving food safety. and helping to restore consumer confidence in the food safety system. i look for two questions and remain available to the subcommittee, thank you. >> thank you. miss bailey. >> thank you mr. chairman, good afternoon. >> i don't know if the mike is on, you don't have a mike geren. >> thank you. i'm months president and ceo of the grocery manufacturers association which represents

more than 300 food, beverage and consumer-products companies. americans enjoy one of the safest food supplies in the world but we recognize that steps can and must be taken to make our food supplies even safer. the we applauded chairman waxman, chairman emeritus dingell, chairman stupak and chairman pallone for developing the food safety enhancement act of 2,009. product safety is the foundation of consumer trust. we look for to working with a quick committee to quickly enough to save the reforms that will restore consumer confidence and continually improve the safety of our food supply. although the food industry is ultimately responsible for the safety of our products strong government oversight is a critical part of our food safety system. that is why gm made supports must in the draft including a proposal to set safety standards for food and vegetables proposals to improve the safety of imported food and food ingredients and proposals to

give fda strong enforcement power to do with bad actors including mandatory recall authority. in particular we strongly support proposals to require all food manufacturers to conduct a hazard analysis to identify potential sources of contamination, and identify appropriate prevented controls and document those preventive controls includes a plan here, we believe that this safety plans are the cornerstone of prevention and that they will help insure the safety is built in from the very beginning. we have proposed modifications to some of these provisions to your staff and will afford to working with you. in particular we look for to working with you to address your concerns about traceability. we recognize that the discussion draft is stocks fda to assess the cost benefits and feasibility of traceability technologies and gives fda the power to exempt certain foods. furthermore recognize that discussion draft and stocks fda

to compile a province of public meetings, however, we believe the studies, meetings and pilot roger should be completed before fda this is how to assign the food industry the responsibility for tracking food product and which coding and identification systems may be the best suited to this task as you anticipate in the draft, the cost and feasibility of requiring every manufacturer to maintain the full pedigree of every ingredient in every food may outweigh the public health benefits. to address concerns raised during the pinette product recall, we urge you to consider whether intimated distributors and brokers should include on the labeling of their bulk ingredients the identity of the increases apply here. in general we support proposals to get the fda stronger enforcement powers including the power to order a recall. we believe the answer and enforcement provisions of the discussion draft such as mandatory recall and suspension of registrations should only be

exercised by senior agency officials when there's a risk of serious adverse health consequences and should ensure that companies are reporting certain to process protection such as administrative hearing. as we saw during the recent recalls of tomatoes and jalapeno peppers, recalls can have devastating financial impact. and the need to reflect the best science and why this agency judgment. finally we strongly support average to provide fda with additional resources, gma helped create allies for stronger fda and we have worked with other consumer and industry groups to increase fda spending. of congress and ask that fyi 2010 request of the fda and obama administration we will have seen food safety spending at the fda increase by 80 percent since 2006. more bunning is needed, with a four to working with the committee to identify the appropriate role for industry and our industry is significantly increase our own investment for food safety and we are prepared to make additional investments to

continually improve the safety of our food safety supply and to comply with many of the new mandates that are envisioned in the discussion draft. we are not opposed to all fees and i'm confident the committee can reach a bipartisan consensus on the agency's resources needs an appropriate role for industry. that may close by saying again that the food and beverage industry is committed to working with you to quickly enact a safe to legislation which makes the prevention of contamination the foundation of our food safety system. thank you. >> thank you. >> thank you very much. thank you for your leadership, chairman pallone, and also the leadership of many other members of the subcommittee and committee. and also thank you to you're ranking member deal for the many hearings we have sat through. we have listened to the witnesses. this work has been going on for a long time and i think

hopefully we are nearing an end in. and my name is caroline smith dewaal, director of food safety for the center for science in the public interest, but today i am representing 10 consumer public health and victims' advocacy organizations that are members of the safe food coalition. it let me begin by saying that we believe that this is a strong bill that will improve food safety. it requires food companies to build into their processes the, not their regular hazard analysis and the have to institute preventive controls to prevent problems from occurring. it provides a modern framework for food safety oversight to replace the antiquated food safety laws that have hamstrung the food and drug administration. mcginnis fda as central authority to carry out the mission of preventing illnesses

and outbreaks, and to inspect food plants much more frequently and it addresses the funding issues urgently needed to institute the programs improvement. doing this with a modest registration page. the hearts of any active reform effort lies and prevention, which is in in the bills hazard analysis and preventive control section. the bill provides fda with new tools like written plans and access to processing records that will allow government inspectors to review the conditions and plans overtime. not just when inspectors are in the facility. we recommend additional strengthening of the bill by requiring companies or labs to report pathogens on final product samples to fda when ever they are encountered in a facility. this would give fda an early

warning of problems and might prevent another tragedy by the outbreak linked to the peanut corporation of america of. it is a common added that you cannot detect which you don't inspect. random and frequent inspection by public officials is a necessary component of an effective food safety system. this legislation divides' food companies into three categories based on risk and iraq's fda to inspect the facilities every six months to four years. while this is a vast improvement over fda's existing program, we continue to believe that more frequent inspections are needed to take nearly a high risk facility's. risk-based inspection is a concept that expands across the entire spectrum of food products, not just those regulated by fda. the registration fee as proposed

is quite modest, and at a thousand dollars per facility it should provide it summer between the 300 and $400 million in new revenue for thune safety activities. let's put this be into context. in the peter pan outbreak, the average cost per victim reporting and no less was $2,650. and this is based on an estimate using the economic research service cost calculator, so when there is an outbreak consumers who are affected may pay over $2,500 or more. these are individuals, so clearly a thousand dollar fee on each facility to avoid these problems is more than reasonable. especially when compared to the cost of individuals and families that you have had here before this committee testifying on a

severe impact of foodborne illness. in addition, i would just like to note that companies themselves can run advertising campaigns to promote their products that run into the tense and even hundreds of millions of dollars. to conclude, i just want to say that the polling has shown that the public has lost confidence in the safety of food and. the percentage of consumers confidence in food safety fell to about 22%, according to the university of minnesota's food industry center. this legislation provides a modern framework for fda's regulation of the food supply that will deliver many benefits to consumers, though it does stop short of structural reforms so we also think are essential. we appreciate your leadership and we believe that these new

authority is that you are proposing will over time prevent the outbreak san illnesses and help restore consumer confidence. earlier this year, members of the energy and commerce committee made commitments to the victims of the peanuts corporation of america outbreak, the change would come to fda. president obama said at a bare minimum we should be able to count on our government keeping our kids say when they eat peanut butter. we urge you to have swiftly to finalize this legislation and to enact it. thank you. >> thank you. dr. jones. >> mr. chairman and members of the subcommittee, thank you to be here today. the recent high-profile outbreaks demonstrate the huge challenges and opportunities for piven in the nation's food supply this ap infrastructure. laws and policies to be frank philosophies developed decades ago no longer suffice.

two successfully meet the new demands. the legislation we're discussing is there for a critical step in reviving the food safety capacities of the fda. i work in a state health department as an epidemiologist responsible for investigating foodborne diseases and in effect cleaning up the mess left when things go awry in the food safety chain. i'm excited to see this proposed legislation addresses many of the problems i experience firsthand. in my role of investigating and helping prevent foodborne disease. improving the traceability of food called for in this legislation is fundamental to successfully achieving many of the other tasks described herein and traced back information have been more broadly available in shared pastor at the many other problems associated with the reason to made a jalapeno incidents could have been mitigated and likewise tracing peanut butter from one plant to 4,000 different commercial products would have been utterly impossible and types of foods.

ensuring that all foods are traceable efficiently and accurately is critical to maintaining food safety. contamination of producer of foods which are eaten uncooked or a particular concern, because consumers have less control of the safety of those foods in their own kitchens. setting standards for pre harvest food production starts major gap in the food safety system. some suspect in protists associated ellises are particularly difficult to investigate the both of public health and regulatory perspectives. while large food service corporations and their suppliers often have excellent quality control programs, with impeccable records, many other companies don't. the portions of this bill requiring country of origin labeling and improve distribution records and plans to regulate this a production of harvesting the fruits and vegetables are important to help address the problems. i am pleased to see that the agency is being encouraged two markedly increase